Drugs

FDA Seeks Drug Firms for Site Visitation Program

FDA says it is now accepting proposals from drug companies to participate in its fiscal year 2025 site visitation program, which is part of the agency’s ongoing effort to gain deeper insight into drug development and commercial manufacturing. The CDER Office of Pharmaceutical Quality (OPQ) program allows FDA staff to visit commercial manufacturing sites, pilot plants, and testing operations to observe facilities firsthand, according to an agency notice. It also aims to strengthen reviewers' understanding of industry's complex processes and challenges impacting the development and lifecycle of drugs.

Companies that develop and manufacture both active pharmaceutical ingredients — whether small or large molecules — and drug products are encouraged to apply, the notice says. The selection of sites will depend on the agency’s training priorities, the compliance status of the facilities, and other factors.

The program provides opportunities for groups of up to 15 FDA staff members to observe essential aspects of pharmaceutical operations over one to two days. Activities may include tours of manufacturing and laboratory facilities, along with industry presentations on drug development, manufacturing, and testing.

Companies interested in participating can submit proposals or seek further information by emailing CDEROPQSiteVisits@fda.hhs.gov.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome